CK-MB ASSAY, CATALOGUE NUMBER 317-10— 510(k) K942773

Name: FDA 510(k) clearance K942773
Creator: U.S. Food and Drug Administration
Published: 1994-08-24

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K942773 for CK-MB ASSAY, CATALOGUE NUMBER 317-10, Substantially Equivalent on 1994-08-24. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1994-06-13
Decision date: 1994-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Download summary PDF View on FDA.gov ↗

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